Opioid REMS: Committee Rejects FDA Proposal, But Sponsors Should Embrace It

The combined Anesthetic & Life Support Drugs and Drug Safety & Risk Management advisory committees voted strongly (25-10) against FDA’s proposed classwide educational REMS for long-acting opioids; but the vote does not stop the process. In fact, FDA may have achieved much of what it set out to do by just by proposing a class REMS in the area.